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| Product NDC Code | 0121-0970 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Lidocaine pain relief |
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| Type | Generic | ||||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | PATCH | ||||||
| RxCUI drug identifier | 1737778 | ||||||
| Application Number | 505G(a)(3) | ||||||
| Labeler Name | PAI Holdings, LLC dba PAI Pharma | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient(s) Lidocaine 4%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Adults and children over 12 years: clean and dry affected area remove film from patch and apply to the skin apply one patch to affected area not more than 3 to 4 times a day remove patch from the skin after at most 12-hour application Children under 12 years of age: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients dihydroxyaluminum aminoacetate, disodium edetate, gelatin, glycerin, kaolin, methylparaben, polyacrylic acid, polyvinyl alcohol, propylene glycol, propylparaben, sodium carboxymethylcellulose, sodium polyacrylate, D-sorbitol, tartaric acid, urea, water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Temporary relief of pain
Purpose
Information about the drug product’s indications for use.Purpose Topical anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Lidocaine Pain Relief Lidocaine Pain Relief LIDOCAINE LIDOCAINE DIHYDROXYALUMINUM AMINOACETATE EDETATE DISODIUM GELATIN GLYCERIN KAOLIN METHYLPARABEN POLYACRYLIC ACID (250000 MW) POLYVINYL ALCOHOL (100000 MW) PROPYLENE GLYCOL PROPYLPARABEN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED SODIUM POLYACRYLATE (2500000 MW) SORBITOL TARTARIC ACID UREA WATER
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel lidocaine patch lidocaine-patch
Principal Display Panel - 30 patches NDC 0121-0970-30 Lidocaine Pain Relief Patch 4% Lidocaine / Topical Anesthetic Lidocaine Pain Relief 30 Patches
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Distributed by MADE IN JAPAN C09750050222 R02/22 PAI LOGO
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use more than one patch at a time on wounds or damaged, broken or irritated skin if you are allergic to any ingredients of this product
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Comments or Questions: 1-800-845-8210 ††This product is not manufactured or distributed by Chattem, Inc., distributor of Aspercreme® Lidocaine Patch.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering conditions worsen symptoms persist for more than 7 days symptoms clear up and occur again within a few days
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product use only as directed • read and follow all directions and warnings do not allow contact with eyes and mucous membranes do not bandage tightly • do not apply local heat such as a heating pad do not use other topical anesthetics at the same time
Pregnancy or breast feeding
Pregnancy or Breast feedingif pregnant or breast-feeding, ask a healthcare professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only Do not use more than one patch at a time on wounds or damaged, broken or irritated skin if you are allergic to any ingredients of this product When using this product use only as directed • read and follow all directions and warnings do not allow contact with eyes and mucous membranes do not bandage tightly • do not apply local heat such as a heating pad do not use other topical anesthetics at the same time Stop use and ask a doctor if localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering conditions worsen symptoms persist for more than 7 days symptoms clear up and occur again within a few days if pregnant or breast-feeding, ask a healthcare professional before use. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API